CLASS II Drug recall · Reported 14 Nov 2018 · FDA Enforcement Report
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride) recalled
S.C. Johnson Professional is recalling Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13% cartridge, distributed in North Carolina. The recall was initiated on 26 Oct 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0221-2019
- FDA event ID
- 81453
- Recalling firm
- S.C. Johnson Professional, Charlotte, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Oct 2018
- FDA classified
- 6 Nov 2018
- Reported
- 14 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Hand Sanitizer
Timeline
| 26 Oct 2018 | Recall initiated by company | |
| 6 Nov 2018 | Classified by FDA | +11 days |
| 14 Nov 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Product was released to market prior to microbiological testing.
Product as listed by the FDA
Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.
Where it was distributed
NC
Questions about this recall
Why was it recalled?
CGMP Deviations: Product was released to market prior to microbiological testing.
Which lots are affected?
Lot 9085
Where was it sold?
NC
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 81453| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride) recalledRefresh Antibac Foam | S.C. Johnson Professional | Manufacturing (CGMP) Deviations | NC |
More recalls from S.C. Johnson Professional
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | deb stoko, Refresh AntiBac FOAM (benzalkonium chloride) recalledRefresh Antibac Foam | S.C. Johnson Professional | Manufacturing (CGMP) Deviations | NC |